Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria

NCT ID: NCT00935389

Last Updated: 2011-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.

Detailed Description

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Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.

Conditions

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Lupus Nephritis Proteinuria CTX

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immunosuppressor

TW 30mg,q.d.\*3 months and reduced into 20mg b.i.d

Group Type EXPERIMENTAL

tripterygium glycosides

Intervention Type DRUG

The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.

Interventions

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tripterygium glycosides

The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.

Intervention Type DRUG

Other Intervention Names

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TW

Eligibility Criteria

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Inclusion Criteria

1. SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
2. Urine protein≥3.0g/24h, Alb\<30g/L and Scr\<1.5mg/dL.
3. All cases are type IV, confirmed by renal biopsy.
4. All patients sign the informed consent and be willing to follow-up on time

Exclusion Criteria

1. Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
2. Scr level above 1.5mg/dL, lasts more than 3 months.
3. Heart, lung or central nervous systems involved or combined with severe infection.
4. With liver function abnormal, ALT or AST being two times above the normal.
5. Pregnant women or patients still in lactation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Nanjing University

Principal Investigators

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Hu Weixin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital, China

Locations

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Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Research Institute of Nephrology,Jinling Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NJCT-0903

Identifier Type: -

Identifier Source: org_study_id

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